The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects
Phase 1
Completed
- Conditions
- Chronic Hepatitis c
- Interventions
- Drug: Kangdaprevir Sodium TabletDrug: placebo
- Registration Number
- NCT03811678
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief Summary
The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.
- Detailed Description
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Able to comprehend and sign the ICF voluntarily prior to initiate the study;
- Able to complete the study according to the protocol;
- Between 18 and 45 years of age（18 and 45 are inclusive）;
- Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2（18 and 28 are inclusive）;
- Physical examination and vital signs without clinically significant abnormalities.
Exclusion Criteria
- Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
- Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
- Donated blood or massive blood loss within 3 months before screening (>450 mL）;
- Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
- Have take any drug that changes liver enzyme activity within 1 month before taking the study drug
- Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
- Have participated in any clinical trial or taken any study drug within 3 months before dosing;
- Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
- Have taken any alcoholic products within 24 hours prior to taking the study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 600 mg single dose placebo Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 200 mg single dose placebo Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 400 mg single dose Kangdaprevir Sodium Tablet Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 400 mg single dose placebo Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 800 mg single dose Kangdaprevir Sodium Tablet Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 100 mg multiple dose placebo Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. 800 mg single dose placebo Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 50 mg single dose Kangdaprevir Sodium Tablet It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 200 mg single dose Kangdaprevir Sodium Tablet Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 100 mg multiple dose Kangdaprevir Sodium Tablet Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. 50 mg single dose placebo It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 400 mg multiple dose Kangdaprevir Sodium Tablet Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. 100 mg single dose Kangdaprevir Sodium Tablet Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study. 100 mg single dose placebo Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study. 200 mg multiple dose Kangdaprevir Sodium Tablet Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. 600 mg single dose Kangdaprevir Sodium Tablet Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2). 200 mg multiple dose placebo Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days. 400 mg multiple dose placebo Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
- Primary Outcome Measures
Name Time Method MRT predose to 72 hour after dosing Mean Residence Time
Adverse events Baseline to day 13 To assess the tolerability after a single and multiple dose of HEC84048
Cmax predose to 72 hour after dosing Maximum observed plasma concentration of HEC84048
Tmax predose to 72 hour after dosing Time of the maximum observed plasma concentration of HEC84048
Vz/F predose to 72 hour after dosing Apparent volume of distribution
T1/2 predose to 72 hour after dosing Terminal elimination half-life
CL/F predose to 72 hour after dosing Oral clearance
AUC predose to 72 hour after dosing Area under the plasma concentration-time curve (AUC)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
the First Hospital of Jilin University
🇨🇳Changchun, Jilin, China